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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH MOTOR HANDPIECE MAX 16000 RPM

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RICHARD WOLF GMBH MOTOR HANDPIECE MAX 16000 RPM Back to Search Results
Model Number 89955.0003
Device Problem Intermittent Continuity (1121)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturer reported: during the inspection of the motor handpiece max.16000rpm in the specialist department according to (b)(4), a short circuit (coil-ground, coil-housing) was detected.After production, the motor handpiece max.16000rpm type 89955.0003 will be subjected to final inspection according to (b)(4).These inspection steps ensure that no products are shipped that do not met their specifications.Since neither a processing/manufacturing defect nor customer fault can be identified, the cause of the short circuit cannot be clearly traced.The motor handpiece max.16000rpm type 89955.0003 with the serial number (b)(4) was produced on 23.04.2020 (with a batch size of 5 pieces) and delivered to the customer on 12.05.2020.A review of the production schedule did not reveal any deviations nor could any special releases be identified.There is no direct patient risk, since in the event of a defect there is no loss of parts and no irreversible damage.In general, the user is advised in the associated ga-a238 instructions for use under chapter four (4) that a visual and functional check must be performed before and after each use.Possible damage/malfunctions of the above type can be easily detected by the hospital staff if these instructions are followed.In our risk analysis e5-2, manufacturing-related, handling-related and design-related hazards with regard to a functional impairment as well as risks due to a product that cannot be used were considered with the corresponding extent of damage and the assumed probability of occurrence and assessed with an acceptable risk.In the period under consideration, no comparable case of this type 89955.0003 with "coil - short circuit" has been registered.As no new risks have arisen from the investigation of the current complaint case, the risk assessment described facts continues to be valid.No manufacturing defect.Based on the results described above the cause of the fault, short-circuit, at the coil is not comprehensible.Measures are not necessary due to the test results and because this is an individual case of this type richard wolf gmbh (rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of rwgmbh report on behalf of rwgmbh.
 
Event Description
It was reported to rw gmbh by the user facility that "accessories motor shaver break off, surgery delay of five (5) hours and surgery was close to the nerve".
 
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Brand Name
MOTOR HANDPIECE MAX 16000 RPM
Type of Device
MOTOR HANDPIECE
Manufacturer (Section D)
RICHARD WOLF GMBH
pforzheimer strasse 32
knittlingen, 75438
GM  75438
Manufacturer (Section G)
RICHARD WOLF GMBH
pforzheimer strasse 32
knittlingen, 75438
GM   75438
Manufacturer Contact
heiko seider-biedermann
pforzheimer strasse 32
knittlingen, 75438
GM   75438
MDR Report Key11856460
MDR Text Key251978865
Report Number9611102-2021-00019
Device Sequence Number1
Product Code GEY
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K080617
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Remedial Action Replace
Type of Report Initial
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number89955.0003
Device Catalogue Number89955.0003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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